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Thursday, October 31, 2024

FDA issued 2 citations in cities across Williamson County in Q3

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There was one company in a city associated with Williamson County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous quarter.

The citations in the county were 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established' and 'Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual and clearly identified'.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies located within Williamson County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLCDevices07/03/2024Lack of or inadequate complaint procedures
NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLCDevices07/03/2024Evaluation, timeliness, identification

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